Labor PainNCT03648099
Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth
A study testing Labor dance and Music in people with Labor Pain and Fear of Childbirth, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to investigate the effect of labor dance and music used during the active phase of labor on labor pain and fear of childbirth. The study was designed as a single-blind randomized controlled intervention trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Fear of Childbirth
- What is being tested?
- Labor dance and Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2018to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An indication for vaginal delivery
- Primipara
- Cervical dilatation of 3 cm or over
- Full-term pregnancy (38-42 gestational weeks)
- Single healthy fetus in vertex position
- No complication that can cause dystocia in labor (such as contraction anomalies, birth object, birth canal associated dystocia, maternal psychology associated dystocia)
Show all 10Show fewer
- Not using analgesia and anesthesia during the first phase of the labor
- Having no physical disability to dance
- Having no difficulty to take upright position and move
- Having no communication problem.
Who cannot join
- Giving up participating in the study
- Abnormal changes in fetal heartbeat
- Emergence of an unexpected complication in the pregnant woman or the fetus 4) Taking analgesics and anesthesia
- 5) Incomplete intervention and follow-up due to rapid labor 6) Being taken to C/S before the completion of the intervention and follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted to investigate the effect of labor dance and music used during the active phase of labor on labor pain and fear of childbirth. The study was designed as a single-blind randomized controlled intervention trial. The participants included in sample are taken into 3 groups (totally 93 participants). A total of 93 individuals, 31 of whom were in the dance group (D), 30 in the music group (M), and 32 in the control group (C), were included in the survey. Data were collected between 15 February 2018 and 15 June 2018 by means of a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA).
Read the detailed description
The study was designed as a single-blind randomized controlled trial with one control and two intervention groups. The aim of the study was to investigate the effect of labor dance and music used in the active phase of labor on perceived labor pain and fear of childbirth.
The hypotheses of our study are as follows:
H1: The labor dance used in the active phase of labor has an effect on reducing the perceived labor pain.
H2: The music used in the active phase of labor has an effect on reducing the perceived labor pain.
H3: The labor dance used in the active phase of labor has an effect on reducing the fear of childbirth.
H4: The music used in the active phase of labor has an effect on reducing the fear of childbirth.
H5: The labor dance is a more effective method in reducing the labor pain perceived in the active phase of labor compared to music.
H6: The labor dance is a more effective method in reducing the fear of childbirth in the active phase of labor compared to music.
There were three groups in the study: the dance group (D) which involved pregnant women who performed the labor dance; the music group (M) involving pregnant women who were exposed to music; the control group (C) which included pregnant women who were administered routine hospital practices. The sampling included pregnant women who met the inclusion criteria and agreed to participate in the study. D; The pregnant women performed labor dance when the cervical dilatation reached 4-5 cm. The dance was performed in the company of music played through headphones. The labor dance lasted 30 minutes. M; The pregnant women listened to music for 30 minutes when the cervical dilatation reached 4-5 cm. They took any position they wanted while listening to music. C; No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study. They were administered routine hospital applications.The study data were collected using a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA). After the pregnant women were randomly assigned to groups, the personal information form was filled in. The perceived pain and fear of the pregnant women in group D and group M were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). A 30-minute long intervention was administered in groups D and M. The pain and fear measurements were repeated soon after the intervention, 30 minutes and 60 minutes after the intervention. On the other hand, the pain and fear assessments in the control group were made when the cervical dilatation reached 4-5 cm. The assessment of the perceived pain and fear in controls who were administered routine hospital practices were repeated 30 minutes after the first measurement, after 60 minutes, and after 90 minutes .
- Conditions
- Labor Pain, Fear of Childbirth
- Being tested
- Labor dance, Music
- Keywords
- Labor Pain, Labor dance, Music, Fear of childbirth
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor danceBehavioural
The dance group which involved pregnant women who performed the labor dance
MusicBehavioural
The music group involving pregnant women who were exposed to music.
| Study group | Role | What they receive |
|---|---|---|
| Labor Dance and music groups | Experimental | 1. Labor Dance; The pregnant women performed labor dance when the cervical dilatation reached 4-5 cm. The dance was performed in the company of music played through headphones.
2. The pregnant women listened to music for 30 minutes when the cervical dilatation reached 4-5 cm. They took any position they wanted while listening to music. Receives: Behavioral: Labor dance; Behavioral: Music |
| Control group | No intervention | The control group: No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study. They were administered routine hospital applications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score,
The perceived pain pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm).
Assessed the labor pain level with Visual Analogue Scale score. This is a 10 cm scale which is labeled "no pain" at one end and "severe pain" at the other end. (0=no pain; 10= pain as bad as can be). Increasing scores indicate women's labor pain.
Measured: Baseline
Secondary outcomes (3)
Version A of the Wijma Delivery Expectancy Questionnaire Score
The fear pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). Assessed childbirth of fear with version A of the Wijma Delivery Expectancy. Questionnaire score. The minimum and maximum scores that can be obtained from the scale range between 0 and 165. Increasing scores indicate women's fear of childbirth.
Measured: Baseline
Recurrence of Fear of Childbirth
A 30-minute long intervention was administered in groups Dance and Music. The fear measurements were repeated soon after the intervention, 30 minutes and 60 minutes after the intervention. Assessed childbirth of fear with version A of the Wijma Delivery Expectancy. Questionnaire score. The minimum and maximum scores that can be obtained from the scale range between 0 and 165. Increasing scores indicate women's fear of childbirth.
Measured: 30 minutes, 60 minutes and 90 minutes
Recurrence of perceived pain
Measurements were repeated 30 minutes after the first measurement, after 60 minutes, and after 90 minutes.
Assessed the labor pain level with Visual Analogue Scale score. This is a 10 cm scale which is labeled "no pain" at one end and "severe pain" at the other end. (0=no pain; 10= pain as bad as can be). Increasing scores indicate women's labor pain.
Measured: 30 minutes, 60 minutes and 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Feb 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single-blind randomized controlled intervention trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Münevver Gönenç, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648099
- Sponsor's protocol ID
- Study of Labor Dance and Music
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdul-Sattar Khudhur Ali S, Mirkhan Ahmed H. Effect of Change in Position and Back Massage on Pain Perception during First Stage of Labor. Pain Manag Nurs. 2018 Jun;19(3):288-294. doi: 10.1016/j.pmn.2018.01.006. Epub 2018 Apr 19.
PubMed 29680213Whitburn LY, Jones LE, Davey MA, Small R. Women's experiences of labour pain and the role of the mind: an exploratory study. Midwifery. 2014 Sep;30(9):1029-35. doi: 10.1016/j.midw.2014.04.005. Epub 2014 Apr 30.
PubMed 24820004Simavli S, Kaygusuz I, Gumus I, Usluogullari B, Yildirim M, Kafali H. Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. J Affect Disord. 2014 Mar;156:194-9. doi: 10.1016/j.jad.2013.12.027. Epub 2013 Dec 28.
PubMed 24411681Masoudi Z, Akbarzadeh M, Vaziri F, Zare N, Ramzi M. The effects of decreasing maternal anxiety on fetal oxygenation and nucleated red blood cells count in the cord blood. Iran J Pediatr. 2014 Jun;24(3):285-92.
PubMed 25562022Gokyildiz Surucu S, Ozturk M, Avcibay Vurgec B, Alan S, Akbas M. The effect of music on pain and anxiety of women during labour on first time pregnancy: A study from Turkey. Complement Ther Clin Pract. 2018 Feb;30:96-102. doi: 10.1016/j.ctcp.2017.12.015. Epub 2017 Dec 19.
PubMed 29389487Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.
PubMed 24762366O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
PubMed 34231203
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth
- ClinicalTrials.gov ID
- NCT03648099
- Acronym / sponsor ID
- Study of Labor Dance and Music
- Conditions
- Labor Pain, Fear of Childbirth
- Keywords
- Labor Pain, Labor dance, Music, Fear of childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to investigate the effect of labor dance and music used during the active phase of labor on labor pain and fear of childbirth. The study was designed as a single-blind randomized controlled intervention trial. The participants included in sample are taken into 3 groups (totally 93 participants). A total of 93 individuals, 31 of whom were in the dance group (D), 30 in the music group (M), and 32 in the control group (C), were included in the survey. Data were collected between 15 February 2018 and 15 June 2018 by means of a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA).
Detailed description
The study was designed as a single-blind randomized controlled trial with one control and two intervention groups. The aim of the study was to investigate the effect of labor dance and music used in the active phase of labor on perceived labor pain and fear of childbirth.
The hypotheses of our study are as follows:
H1: The labor dance used in the active phase of labor has an effect on reducing the perceived labor pain.
H2: The music used in the active phase of labor has an effect on reducing the perceived labor pain.
H3: The labor dance used in the active phase of labor has an effect on reducing the fear of childbirth.
H4: The music used in the active phase of labor has an effect on reducing the fear of childbirth.
H5: The labor dance is a more effective method in reducing the labor pain perceived in the active phase of labor compared to music.
H6: The labor dance is a more effective method in reducing the fear of childbirth in the active phase of labor compared to music.
There were three groups in the study: the dance group (D) which involved pregnant women who performed the labor dance; the music group (M) involving pregnant women who were exposed to music; the control group (C) which included pregnant women who were administered routine hospital practices. The sampling included pregnant women who met the inclusion criteria and agreed to participate in the study. D; The pregnant women performed labor dance when the cervical dilatation reached 4-5 cm. The dance was performed in the company of music played through headphones. The labor dance lasted 30 minutes. M; The pregnant women listened to music for 30 minutes when the cervical dilatation reached 4-5 cm. They took any position they wanted while listening to music. C; No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study. They were administered routine hospital applications.The study data were collected using a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA). After the pregnant women were randomly assigned to groups, the personal information form was filled in. The perceived pain and fear of the pregnant women in group D and group M were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). A 30-minute long intervention was administered in groups D and M. The pain and fear measurements were repeated soon after the intervention, 30 minutes and 60 minutes after the intervention. On the other hand, the pain and fear assessments in the control group were made when the cervical dilatation reached 4-5 cm. The assessment of the perceived pain and fear in controls who were administered routine hospital practices were repeated 30 minutes after the first measurement, after 60 minutes, and after 90 minutes .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- a single-blind randomized controlled intervention trial
| Arm | Type | Receives |
|---|---|---|
| Labor Dance and music groups | Experimental | Behavioral: Labor dance, Behavioral: Music1. Labor Dance; The pregnant women performed labor dance when the cervical dilatation reached 4-5 cm. The dance was performed in the company of music played through headphones. 2. The pregnant women listened to music for 30 minutes when the cervical dilatation reached 4-5 cm. They took any position they wanted while listening to music. |
| Control group | No intervention | –The control group: No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study. They were administered routine hospital applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- An indication for vaginal delivery
- Primipara
- Cervical dilatation of 3 cm or over
- Full-term pregnancy (38-42 gestational weeks)
- Single healthy fetus in vertex position
Key exclusion criteria (4 listed)
- Giving up participating in the study
- Abnormal changes in fetal heartbeat
- Emergence of an unexpected complication in the pregnant woman or the fetus 4) Taking analgesics and anesthesia
- 5) Incomplete intervention and follow-up due to rapid labor 6) Being taken to C/S before the completion of the intervention and follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor danceThe dance group which involved pregnant women who performed the labor dance | Behavioural | Labor Dance and music groups |
| MusicThe music group involving pregnant women who were exposed to music. | Behavioural | Labor Dance and music groups |
Primary outcome
Visual Analogue Scale Score,
Time frame: Baseline
The perceived pain pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). Assessed the labor pain level with Visual Analogue Scale score. This is a 10 cm scale which is labeled "no pain" at one end and "severe pain" at the other end. (0=no pain; 10= pain as bad as can be). Increasing scores indicate women's labor pain.
3 secondary outcomes
Version A of the Wijma Delivery Expectancy Questionnaire Score
Time frame: Baseline
Recurrence of Fear of Childbirth
Time frame: 30 minutes, 60 minutes and 90 minutes
Recurrence of perceived pain
Time frame: 30 minutes, 60 minutes and 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Background: PubMed 29680213Abdul-Sattar Khudhur Ali S, Mirkhan Ahmed H. Effect of Change in Position and Back Massage on Pain Perception during First Stage of Labor. Pain Manag Nurs. 2018 Jun;19(3):288-294. doi: 10.1016/j.pmn.2018.01.006. Epub 2018 Apr 19.
- Results publication: PubMed 24820004Whitburn LY, Jones LE, Davey MA, Small R. Women's experiences of labour pain and the role of the mind: an exploratory study. Midwifery. 2014 Sep;30(9):1029-35. doi: 10.1016/j.midw.2014.04.005. Epub 2014 Apr 30.
- Results publication: PubMed 24411681Simavli S, Kaygusuz I, Gumus I, Usluogullari B, Yildirim M, Kafali H. Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. J Affect Disord. 2014 Mar;156:194-9. doi: 10.1016/j.jad.2013.12.027. Epub 2013 Dec 28.
- Results publication: PubMed 25562022Masoudi Z, Akbarzadeh M, Vaziri F, Zare N, Ramzi M. The effects of decreasing maternal anxiety on fetal oxygenation and nucleated red blood cells count in the cord blood. Iran J Pediatr. 2014 Jun;24(3):285-92.
- Results publication: PubMed 29389487Gokyildiz Surucu S, Ozturk M, Avcibay Vurgec B, Alan S, Akbas M. The effect of music on pain and anxiety of women during labour on first time pregnancy: A study from Turkey. Complement Ther Clin Pract. 2018 Feb;30:96-102. doi: 10.1016/j.ctcp.2017.12.015. Epub 2017 Dec 19.
- Results publication: PubMed 24762366Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.
- Derived from this study: PubMed 34231203O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labor dance and Music in people with Labor Pain and Fear of Childbirth, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Score, (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648099, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.